Reduced profile central venous access catheter with vena cava filter and method

ABSTRACT

A central access vena cava filter catheter having a multi-lumen catheter body with plural longitudinally extending parallel lumens within the single catheter body, a vena cava filter member disposed at a distal end of the catheter body and an outer sheath concentrically disposed about the multi-lumen catheter body and the vena cava filter member. The vena cava filter member may be removably coupled to the multi-lumen catheter for temporary placement and retrieval under recommended indications.

CROSS-REFERENCE TO RELATED INVENTIONS

This application is a continuation-in-part of co-pending, U.S.application Ser. No. 11/849,225 filed Aug. 31, 2007, published asUS2009-0062840, and is also a continuation-in-part of co-pending U.S.application Ser. No. 12/684,839 filed Jan. 8, 2010 published asUS2010-0217304, and is also a continuation in part of co-pending U.S.application Ser. No. 13/091,826, filed Apr. 21, 2011, published asUS2011-0288578, which is a continuation of U.S. application Ser. No.11/849,225 filed Aug. 31, 2007, published as US2009-0062840, each ofwhich is incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

The present invention pertains generally to the field of vascularfilters for capturing embolic material in the blood flow. Moreparticularly, the present invention relates to multi-lumen centralvenous access catheter of the type typically used for central venousaccess, and which has a vena cava filter at a distal end. The inventivecentral venous access vena cava filter catheter also preferably has atleast one port generally proximal the filter and at least port distalthe filter. The proximal and distal ports provide means for introducinga bioactive agent, such as an anticoagulant or thrombolytic agents,contrast medium, blood transfusions, fluids or medications or as a meansfor withdrawing blood samples for patient testing.

The present invention may be configured for either a femoral approach ora jugular approach to the inferior vena cava. Vena cava filters aretypically deployed infrarenaly, but may also be deployed suprarenaly. Itwill be understood that within the inferior vena cava blood flow issuperior, i.e., toward the patients head. Thus, in all embodiments, thevena cava filter will be positioned so that it opens inferiorly, i.e.,away from the patient's head and toward the direction of the blood flow.It will be appreciated, therefore, that in the present invention, thevena cava filter will have a different axial orientation on the centralaccess catheter depending upon whether the device is intended for use ina femoral approach or a jugular approach.

SUMMARY OF THE INVENTION

The accepted standard of care for patients with venous thromboembolism(VTE) is anticoagulant therapy. Inferior vena cava (IVC) filters arereserved for those patients who fail anticoagulant therapy, or have acomplication or contraindication to anticoagulant therapy. Until theearly 1970's, the only method of IVC interruption was surgical, eitherby clipping, ligation or plication. The first clinical experience of anendoluminally-placed device to interrupt IVC flow was reported byMobin-Uddin et al. in 1969. However, it was not until the introductionof a stainless steel umbrella-type filter by Greenfield et al. in 1973that an effective method of endoluminally trapping emboli whilesimultaneously preserving IVC flow became possible. Indeed, for manyyears, the Greenfield filter set a benchmark by which newer filters weremeasured. Early generations of filters were inserted by surgicalcut-down and venotomy. Eventually filters were able to be insertedpercutaneously: initially through large 24 Fr sheaths, though newergenerations of filters are able to be delivered through 6 Fr systems.

Despite the safety and efficacy of modern day filters, systemicanticoagulation remains the primary treatment for VTE. Eitherunfractionated or low molecular weight heparin followed by three monthsof oral anticoagulation in patients with proximal deep venous thrombosis(DVT) is approximately 94% effective in preventing pulmonary embolism(PE) or recurrent DVT. The routine placement of IVC filters in additionto anticoagulation in patients with documented DVT was investigated byDecousus et al. in a randomized trial. Decousus H, Leizorovicz A, ParentF, et al. A clinical trial of vena caval filters in the prevention ofpulmonary embolism in patients with proximal deep-vein thrombosis. NEngl J Med 1998; 338:409-415. This study revealed that the use of apermanent filter in addition to heparin therapy significantly decreasedthe occurrence of PE within the first 12 days compared to those withouta filter. However, no effect was observed on either immediate orlong-term mortality, and by 2 years, the initial benefit seen in thegroup of patients with filters was offset by a significant increase inthe rate of recurrent DVT.

Despite the efficacy of anticoagulant therapy in the management of VTE,there are certain situations and conditions in which the benefits ofanticoagulation are outweighed by the risks of instituting such atherapy. These include contraindications and complications ofanticoagulant therapy. In such circumstances, there may be absolute orrelative indications for filter insertion

Currently, there are at least eight different types of permanent cavafilters that are FDA approved. These include the Bird's Nest filter(Cook Incorporated, Bloomington, Ind.), Vena Tech LGM filter (B. Braun,Bethlehem Pa.), Vena Tech LP (B. Braun), Simon Nitinol filter (Bard,Covington, Ga.), Titanium Greenfield filter (Boston Scientific, NatickMass.), Over-the-Wire Greenfield filter (Boston Scientific), TrapEasefilter (Cordis Corp.) and the Gunther Tulip filter (Cook Inc.)

Well-founded concerns over the long-term complications of permanent IVCfilters, particularly in younger patients in need of PE prophylaxis witha temporary contraindication to anticoagulation, has led to thedevelopment of temporary and retrievable filters. Temporary filtersremain attached to an accessible transcutaneous catheter or wire. Thesehave been used primarily in Europe for PE prophylaxis duringthrombolytic therapy for DVT. Currently these devices are not approvedfor use in the United States. Retrievable filters are very similar inappearance to permanent filters, but with modifications to the cavalattachment sites and/or hooks at one end that can facilitate theirremoval. Retrievable filters are currently available in the UnitedStates, examples of these include the Gunther Tulip (Cook Inc.), OptEase (Cordis Corp.), and Recovery nitinol filters (Bard PeripheralVascular, Tempe, Ariz.) Lin P H, et al., Vena caval filters in thetreatment of acute DVT. Endovascular Today 2005; January: 40-50. Thetime limit of retrievability is in part dependant on the rate ofendothelialization of the device, which typically occurs within 2 weeks.However, differences in design may extend the time period in which thefilter may be safely retrieved.

Currently no consensus exists as to which patients have an indicationfor a retrievable filter. However, it is generally accepted thatpatients at high risk for pulmonary embolism or with documented PE andwith a temporary contraindication to anticoagulation are candidates.

Certain circumstances preclude the placement of a filter in theinfrarenal IVC. This includes thrombus extending into the infrarenalIVC, renal vein thrombosis or pregnancy. The safety of suprarenalplacement of IVC filters is well documented, with no reported instancesof renal dysfunction and no differences in the rates of filtermigration, recurrent PE or caval thrombosis.

The rate of upper extremity DVT is on the rise. This is predominantlydue to an increasing number of patients having short- and long-termupper extremity central venous access catheters. In one study, 88% ofpatients found to have an upper extremity DVT had a central venouscatheter present at the site of thrombosis at the time of diagnosis orwithin the previous two weeks. Pulmonary embolism may complicate upperextremity DVT in 12-16% of cases. In patients who have such acomplication or contraindication to anticoagulation, a filter can besafely placed immediately below the confluence of the brachiocephalicveins. However, misplacement of an SVC filter is theoretically morelikely than with an IVC filter because of the relatively short targetarea for deployment.

The most common imaging modality used for filter insertion isfluoroscopy, performed either in an interventional suite or an operatingroom. Bedside placement of filters has inherent advantages, particularlyfor critically ill patients in intensive care settings where transportcan be avoided. Portable fluoroscopy, surface duplex ultrasound andintravascular ultrasound (IVUS) have all been used to assist withbedside filter placement.

Vena cava filter placement frequently occurs concomitantly with centralaccess line placement or in critically ill patients that already have acentral access line in place. Heretofore, however, there have been nodevices which combine the function of a central access catheter and avena cava filter mounted on the central access catheter to provide bothcentral access and embolic protection.

Accordingly, it is an objective of the present invention to provide amulti-lumen catheter coupled to a vena cava filter that is useful bothas a central venous access catheter for administration of intravenousfluids, bioactive agents, contrast agents, flushing agents, pressurizedfluids for mechanical thrombolysis and/or withdrawal of blood samplesand for capture of thrombus or emboli.

Another aspect of the present invention is to provide a filter geometryin which the proximal portion of the filter, relative to the axis ofblood flow, has larger interstitial openings to permit thrombus orembolic material to flow into the filter, while the distal portion ofthe filter, again relative to the axis of blood flow, has relativelysmaller interstitial openings that capture the thrombus or embolicmaterial within the filter. Another way to view this aspect is that thestructure of the filter includes a greater open surface area exposed tothe flow of embolic material into the filter at its proximal end, whilethe distal end has smaller open surface area exposed to the flow ofembolic material to capture the embolic material in the distal end ofthe filter member.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a central venous access vena cava filtercatheter in accordance with a first embodiment of the present inventionwith the vena cava filter in an unexpanded state.

FIG. 2 is a side elevational view of a central venous access vena cavafilter catheter in accordance with the first embodiment of the presentinvention.

FIG. 3. is a cross-sectional view taken along line 3-3 of FIG. 2.

FIG. 4 is a cross-sectional view taken along line 4-4 of FIG. 2.

FIG. 5 is a cross-sectional view taken along line 5-5 of FIG. 2.

FIG. 6 is a perspective view of a central venous access vena cava filtercatheter in accordance with a second embodiment of the present inventionillustrating the vena cava filter in an unexpanded state.

FIG. 7 is a side elevational view of a central venous access vena cavafilter catheter in accordance with the second embodiment of the presentinvention.

FIG. 8 is a cross-sectional view taken along line 8-8 of FIG. 7.

FIG. 9 is a cross-sectional view taken along line 9-9 of FIG. 7.

FIG. 10 is a cross-sectional view taken along line 10-10 of FIG. 7.

FIG. 11 is a cross-sectional view taken along line 11-11 of FIG. 7.

FIG. 12 is a perspective view of the central venous access vena cavafilter catheter of FIG. 1 illustrating the vena cava filter in adiametrically expanded state.

FIG. 13A is a perspective view of a vena cava filter member inaccordance with a first embodiment thereof.

FIG. 13B is a first side elevational view thereof.

FIG. 13C is an end elevational view thereof.

FIG. 13D is a second side elevational view thereof.

FIGS. 14A-14H are perspective views of alternative embodiments of a venacava filter member in accordance with the present invention.

FIG. 15A-15H are fragmentary side elevational views of the alternativeembodiments of the vena cava filter member illustrated in FIGS. 14A-14H.

FIG. 16A is a side elevational view of the inventive central access venacava filter catheter in its undeployed state.

FIG. 16B is a side elevational view of the inventive central access venacava filter catheter in its deployed state.

FIGS. 17A-17D are transverse cross-sectional views of alternativeconfigurations of the multi-lumen catheter depicted within an outersheath and taken along lines 17A-17A, 17B-17B, 17C-17C and 17D-17D ofFIGS. 18A-18D respectively.

FIGS. 18A-18D are perspective views of alternative embodiments of themulti-lumen catheter within the outer sheath in accordance with thepresent invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In the accompanying Figures like structural or functional elements aredesignated by like reference numerals, e.g., 16, 116, 216, 316, 416represent similar structural or functional elements across differentembodiments of the invention. With particular reference to FIGS. 1-5,according to a first embodiment of the invention, there is disclosed acentral venous access filter (“CVAF”) 10 that is composed generally of amulti-lumen central venous access catheter body 12 having a proximalport 32 associated with a first lumen 44 and a distal port 34 associatedwith a second lumen 42, a filter member 16, having a first end 18 and asecond end 20, is positioned generally intermediate the distal port 34and the proximal port 32 and is generally concentric relative to thecatheter body 12. An outer sheath 22 is concentrically disposed over thecatheter body 12 such that relative movement of the catheter body 12 andthe outer sheath 22 either exposes the filter member 16 or captures thefilter member 16 within the outer sheath 22. The outer sheath 22terminates in an annular opening at a distal end thereof and at firsthub member 225 as depicted in FIGS. 16A and 16B. The proximal hub 225will be described more fully hereinafter. The catheter body 12 extendsthrough a central bore in the proximal hub 225 and passes through acentral lumen of the outer sheath 22. A second hub member 227, asdepicted in FIGS. 16A and 16B, is coupled to a proximal end of thecatheter body 12. The second hub member 227 and the first hub member 225are removably engageable with each other as will also be describedfurther hereinafter.

Depending upon the orientation of the filter member 16, the first end 18or the second end 20 may either be fixed or moveable relative to thecatheter body 12. Alternatively, as will be discussed furtherhereinafter, the filter member 16 may have only a first end 18 which isfixed to the catheter body 12

To facilitate percutaneous introduction of the inventive CVAF 10, aphysician may optionally elect to employ an outer sheath (not shown) asvascular access conduit for the CVAF 10. The presence of the filtermember 16 at the distal end of the catheter body 12 creates a region ofrelatively lower flexibility and the practitioner may determine itbeneficial to employ an outer sheath for vascular access.

As used in this application, unless otherwise specifically stated, theterms “proximal” and “distal” are intended to refer to positionsrelative to the longitudinal axis of the catheter body 12. Those skilledin the art will understand that the catheter body 12 has a distal endwhich is first inserted into the patient and a proximal end whichopposite the distal end. Additionally, the terms “inferior” or“inferiorly” are intended to refer to the anatomic orientation of beingin a direction away from the patient's head while the terms “superior”or “superiorly” are intended to refer to the anatomic orientation ofbeing toward the patient's head.

The multi-lumen aspect of the inventive central venous access filtercatheter 10 is shown more clearly in FIGS. 2-5. The catheter body 12 hasa proximal section 13 and distal section 14 which has a relativelysmaller diametric profile than the proximal section 13. As describedabove, the first lumen 44 terminates at the proximal port 32, while thesecond lumen 42 terminates at the distal port 34. A central guidewirelumen 30 may be provided that extends the entire longitudinal length ofthe catheter body 12 and terminates at the distal end of the catheterbody 12 at a distal guidewire opening 31 that permits the catheter bodyto track along a guidewire during a procedure. The central guidewirelumen 30 may also be used to introduce fluids, such as bioactive agents,intravenous fluids or blood transfusions.

Additionally, at least one of a plurality of infusion lumens 40 areprovided, each having at least one infusion port 36 that passes througha wall of the catheter body 12. Bioactive agents, flushing fluids forflushing or under elevated pressures for mechanical thrombolysis ofthrombus in the filter member 16, contrast agents or other fluids may beinfused through the infusion lumens 40 and out of the at least oneinfusion port 36 to pass into the patient's venous system for eitherlocal or systemic effect. In accordance with one embodiment of theinvention, plural infusion ports 36 are provided with multiple ports 36being provided in communication with a single infusion lumen 40 andspaced along a longitudinal axis of the catheter body 12. Additionally,plural infusion ports 36 may be provided in a circumferentially spacedmanner to provide for fluid infusion at points spaced around thecircumference of the catheter body 12. In this manner, fluid infusion isprovided along both the longitudinal axis and the circumferential axisof the catheter body 12 within the spatial area defined by and boundedby the filter member 16. Because the plural infusion ports 36communicate with the spatial area defined by and bounded by filtermember 16, fluids introduced through the infusion lumens 40 are directedimmediately at thrombus caught within the filter member 16. This permitsthrombolytic agents, high pressure mechanical thrombolysis using apressurized saline flush to be introduced directly to the situs ofthrombus capture within filter member 16. Alternatively, thermal,ultrasound or other types of thrombolysis may be employed to disruptthrombus captured by the filter member 16. For example, the annularspace between the outer sheath 22 and the catheter body 12 may be usedto introduce a thrombolytic to the filter and shower the filter todisrupt thrombus caught by the filter member 16. Additionally, theballoon depicted in FIGS. 21 and 22 may be positioned adjacent thefilter member 16 and be provided with plural openings oriented in thedirection of the filter member 16 to facilitate thrombolysis.

It will be understood, by those skilled in the art, that alternativearrangements of the first lumen 44, the second lumen 42, the guidewirelumen 30, or the infusion lumens are possible and contemplated by thepresent invention. The number and arrangement of lumens in the catheterbody 12 is a function of the desired number of operable ports passingthrough the walls of the catheter body 12, the relative position of theoperable ports, the desired position and geometry of the guidewire lumen30, the desired longitudinal flexibility of the catheter body 12, thedesirable degree of kink resistance of the catheter body 12, and otherfactors which are known to one of ordinary skill in the catheter arts.

While the present invention is not limited to specific dimensional sizesof either the catheter body member 12, the outer sheath 22, lumendiameter or port dimension, an exemplary outer diameter size of theouter sheath 22 is between 8 Fr (2.7 mm) and 9 Fr (3.0 mm) while anexemplary outer diameter size of the catheter member 12 is between 6 Fr(2.0 mm) and 7 Fr. A diametric transition taper 15 may be providedbetween the proximal portion 13 and the distal portion 14 of thecatheter body 12 corresponding to the thickness of the filter member 16.In this manner, the outer surface of the filter member 16 issubstantially co-planar with the outer diameter of the proximal portion13 of the catheter body 12 about its entire circumference.Alternatively, the catheter body member 12 may have a constant diameterand the filter member 16 coupled to an outer surface of the catheterbody member 12, with the outer sheath 22 having a luminal diametersufficient to fit over the filter member 16. Moreover, the fixed firstend 18 of filter 16 is positioned adjacent and in abutting relationshipwith the diametric transition 15, while the moveable second end 20 offilter member 16 is concentrically positioned around the distal section14 of catheter body 12 and is reciprocally moveable thereupon toaccommodate diametric expansion of the filter member 16. Lumen diameterand port dimension are a function of design requirements and arevariable depending upon the desired purpose and function of the lumen orport, e.g., pressure sensing, infusion, evacuation, guidewire, flowsensing, or flow conduit.

In order to aid a physician in visualizing the CVAF 10 in vivo, at leastone radio-opaque or other viewable marker may be provided. A firstmarker 24 is provided at the distal end of the outer sheath 22 and asecond marker 36 may be provided at a distal tip 33 of the catheter body12. It will be understood that when the outer sheath 22 is in itsnon-retracted delivery position, that the filter 16 will be covered andthe marker 24 and the second marker 36 will be adjacent or in closeproximity with one another. Alternatively, the outer sheath 22 may,itself, be made of or include a radio-opaque or other viewable material,such as a metal braid or metal reinforcement within or applied to apolymeric sheath. The first and second markers 24, 36 or the material ofthe outer sheath 22 may enhance visualization of the CVAF 10 underfluoroscopy, ultrasound or other visualization or guidance technique.

FIGS. 6-11 illustrate a second embodiment of the CVAF 50. Unlike CVAF10, CVAF 50 does not include the central guidewire lumen 30 of CVAF 10.Rather, while the general construct of CVAF 50 is similar to that ofCVAF 10, a different configuration of the inner lumens is employed.

CVAF 50, like CVAF 10, consists generally of a multi-lumen centralvenous access catheter body 12 having a proximal port 32 associated witha first lumen 54 and a distal port 34 associated with a second lumen 58,a filter member 16, having a fixed proximal end 18 and a moveable distalend 20, is positioned generally intermediate the distal port 34 and theproximal port 32 and is generally concentric relative to the catheterbody 12. Use of the term “generally intermediate” with respect to thefilter member 16 position is intended to mean that at least asubstantial portion of the filter member 16 resides intermediate thedistal port 34 and the proximal port 32. Thus, the filter member 16 maypartially overlay either or both of the proximal port 32 or the distalport 34.

The catheter body 12 has a proximal section 13 and distal section 14which has a relatively smaller diametric profile than the proximalsection 13. As described above, the first lumen 54 terminates at theproximal port 32, while the second lumen 58 terminates at the distalport 34. An atraumatic tip 52 terminates the catheter body 12 at itsdistal end. The atraumatic tip 52 preferably includes a radio-opaquemarker to aid in positional visualization of the distal end of thecatheter body 12.

A plurality of infusion lumens 56 are provided, each having at least oneinfusion port 36, preferably plural infusion ports 36, that passesthrough a wall of the catheter body 12 and communicates with a spacedefined within an area bounded by the filter member 16. Bioactiveagents, flushing fluids, pressurized mechanical thrombolytic fluids, orother fluids may be infused through the infusion lumens 56 and out ofthe at least one infusion port 36 to pass into the space defined by thefilter member 16 and ultimately into the patient's venous system foreither local or systemic effect. In accordance with one embodiment ofthe invention, the each of the plural infusion lumens 56 are in fluidcommunication with plural ports 36 arrayed along both the longitudinalaxis and the circumferential axis of the catheter body. Thisconfiguration provides for fluid infusion along both the longitudinalaxis and the circumferential axis of the catheter body 12 and in directcommunication with the space defined by the filter member 16 thatcaptures thrombus.

The infusion lumens 56, the first lumen 54 and the second lumen 58 arebounded by and separated from each other by first catheter septum 51 andsecond catheter septum 56 which also aid in providing structural supportfor the catheter body 12. First catheter septum 51 is a generallydiametrically and longitudinally extending member that divides the firstlumen 54 from the second lumen 58 along the longitudinal axis of thecatheter body 12. Second catheter septum 56 may comprise a generallyU-shaped member that intersects the first catheter septum 51 at a loweraspect of the septum and is connected with an inner wall surface of thecatheter body 12 at upper aspects of the septum 51 to define twoinfusion lumens in lateral regions of the catheter body 12.

The filter member 16 has two general configurations. A firstconfiguration consists generally of two opposing generally open conicalsections formed by plural interconnected structural elements definingthe lateral surfaces of each open conical section, wherein the twoopposing generally open conical sections each have open bases facingeach other which are interconnected by a generally cylindrical sectionof the filter member 16. Each open conical section has an open base andan apex, wherein the apices project in opposing directions, with oneapex projecting proximally and another apex projecting distally relativeto the axis of the catheter. The plural interconnected structuralelements forming the lateral surfaces of each generally open conicalsections may be strut-like structural members extending generallyaxially along the longitudinal axis of the filter member 16. The axiallyextending strut-like structural members may be linear members or may becurved members. The apices of each of the generally open conicalsections are formed either of a generally cylindrical collar that servesto couple the filter member 16 to the catheter body 12. The generallycylindrical collar is concentrically engaged about the catheter body 12and may be axially movable thereupon, or is formed by connectionsbetween adjacent pairs of longitudinal strut-like structural memberswhich circumscribe a circumference of the catheter body 12. Thegenerally cylindrical section of the filter member 16 is formed by agenerally open lattice of interconnected structural elements whichconnect the base of a first open conical section to the base of a secondopen conical section. The generally cylindrical section of the filtermember 16 lies in apposition with a vascular wall upon deployment of thefilter member 16 with a vascular lumen.

A second general configuration of the filter member 16 consistsgenerally of a single generally open conical section in which aplurality of longitudinal strut-like structural members form the lateralsurfaces of the conical section and are connected to a generallycylindrical collar which couples the filter member 16 to the catheterbody 12 at an apex of the generally open conical section. The base ofthe generally open conical section is formed by opposing ends of thelongitudinal strut-like structural members. A generally cylindricalsection of the filter member 16, formed of a generally open lattice ofinterconnected structural elements, extends from the longitudinalstrut-like structural members forming the base of the generally openconical section, to provide a region of the filter member 16 which is inapposition to the vascular wall upon deployment of the filter member.

One embodiment of the filter member 16 is illustrated in itsdiametrically expanded configuration in FIGS. 12-13D. In thisembodiment, filter member 16 consists generally of a first end 18 and asecond end 20, each of which consists generally of a tubular structurewhich is circumferentially positioned about a section of the catheterbody 12. One of the first end 18 and second end 20 are fixedly coupledto the catheter body 12, while the other is movable relative to thecatheter body 12. At least one of a plurality of first strut members 62,are coupled at their first end to the first end 18 of filter member 16and each extends axially relative to the longitudinal axis of thecatheter body 12. Each of the first strut members 62 is an elongatemember that, upon diametric expansion of the filter member 16, flaresaway from the central longitudinal axis of the catheter body 12, in agenerally tapered conical manner, and terminates in an end section 63that bends generally parallel to and along the longitudinal axis of thecatheter body 12. A plurality of second strut members 64 are coupled atan end to the second end 20 of filter member 16 and each extendsparallel relative to the longitudinal axis of the catheter body 12. Aplurality of third strut members 66 are coupled at ends thereof to theend of the filter member and each extends parallel relative to thelongitudinal axis of the catheter body 12. It will be appreciated, bythose skilled in the art, that the number of struts employed as thefirst strut members 62, the second strut members 64 and the third strutmembers 66 forming the filter member 16 may be evenly distributed abouta 360 degree circumference and define the lateral wall surfaces of thefilter member 16. A circumferential member 70 extends circumferentiallyto define a circumferential axis of the filter member 16 and has aseries of continuous undulations defining peaks a series of peaks 75 andvalleys 77 about the circumference of filter member 16. Each of theplurality of first strut members 62, the plurality of second strutmembers 64 and the plurality of third strut members 66 are coupled tothe circumferential member 70 at different points about itscircumferential axis and intermediate the proximal end 18 and the distalend 20 of the filter member 16. In its unexpanded state the filtermember 16 has a generally tubular shape, while in its expanded state thefilter member 16 assumes one of the general configurations discussedabove, i.e., either oppositely extending generally open conical sectionsor a single generally open conical section.

The plurality of first strut members 62 are preferably offset from eachother by approximately 120 degrees about the circumference of thecatheter body 12. The plurality of second strut members 64 are alsopreferably offset from each other by approximately 120 degrees. Finally,the plurality of third strut members 66 are also preferably offset fromeach other by approximately 120 degrees. Each of the plurality of firststrut members 62 couple at a junction 76 to hoop or circumferentialmember 70 at a peak thereof. Similarly, each of the plurality of thirdstrut members 66 couple at junction 76 to the hoop or circumferentialmember 70 at a peak thereof. In this manner, a first strut member 62 anda third strut member 66 are each coupled to hoop or circumferentialmember 70 at junction 76 and, in this relationship, form a generallylinear member that extends along the longitudinal axis of the catheterbody and connects between the proximal end 18 of the filter member 16and the distal end 20 of the filter member 16. Each of the second strutmembers 64 couple, at their proximal ends to a valley 77 of the hoop orcircumferential member 70 and connects at a junction 79. Unlike theconnections at junction 76 between the plurality of first strut members62 and the plurality of second strut members, in this embodiment of thefilter member 16, there is no member that connects to junction 79 andextends from the proximal end 18 of the filter member 16. In thisconfiguration, the hoop or circumferential member 70 assumes a generallycircumferential tri-leaflet ring having three peaks 75 and three valleys77.

To facilitate bending and folding of the hoop or circumferential member70 between the expanded and unexpanded states, generally U-shaped hingemembers 74 may be provided at each of the valleys 77 of the hoop orcircumferential member 70. It will be understood that each of theplurality of first strut members 62, plurality of second strut members64, plurality of third strut members 66 and the hoop or circumferentialmember 70 are preferably fabricated of biocompatible materials, such asshape memory alloys, superelastic materials or elastic materials,including, without limitation, titanium, vanadium, aluminum, nickel,tantalum, zirconium, chromium, silver, gold, silicon, magnesium,niobium, scandium, platinum, cobalt, palladium, manganese, molybdenumand alloys thereof, such as zirconium-titanium-tantalum alloys,cobalt-chromium-molybdenum alloys, nitinol, and stainless steel.

FIGS. 14A-14H and corresponding FIGS. 15A-15H depict alternativeembodiments of the filter member 16, labeled 80, 90, 100, 110, 120, 130,140 and 150, respectively. Like filter member 16, each of filter members80, 90, 100, 110, 120, 130, 140 and 150 having a proximal end 18 and adistal end 20 that each consist of a generally ring-like structureintended to circumferentially couple to a catheter body 12 (not shown),with the proximal end 18 being fixed and the distal end 20 beingreciprocally moveable axially along the distal portion 14 of catheterbody 12. Like filter member 16, each of the alternative filter memberembodiments depicted in FIGS. 14A-14H and 15A-15H, consist of aplurality of first strut members 81, 91, 101, 111, 121, 131, 141 and151, respectively, extending distally from the proximal end 18 of thefilter member and a plurality of second strut members 83, 93, 103, 113,123, 133, 143 and 153, respectively, extending proximally from thedistal end 20 of the filter member, with a diametrically expansible hoopor circumferential member 87, 97, 107, 117, 127, 137, 147, 157,respectively, interconnecting the distally extending strut members 81,92, 101, 111, 121, 131, 141 and 151, respectively, with the proximallyextending strut members 83, 93, 103, 113, 123, 133, 143 and 153. In thealternative embodiments of filter members 100, 110 and 120, at leastsome distally extending strut members and at least some of theproximally extending strut members form linear elements that extendalong the entire longitudinal axis of the respective filter member, withthe hoop or circumferential member being comprised of at least oneundulating or serpentine ring structure.

In the alternative embodiments of filter members 80, 90, 130, 140 and150, a plurality of distally extending strut members are provided spacedapproximately 120 degrees apart from one and other about thecircumference of the filter members, and the distally extending strutmembers bifurcating once or twice distally in a generally Y-shapedmanner as in filter members 80, 130, 140 or 150, or the proximallyextending strut members bifurcating proximally in a generally Y-shapedmanner and interconnecting with the distally extending generallyY-shaped strut members to form a diamond-like pattern as in filtermember 90. In filter members 90 and 140, the hoop or circumferentialmember is formed by the diamond-like pattern formed by the intersectionof the plurality of struts. In contrast, in filter members 80, 130 and150, the hoop or circumferential member is formed by at least oneundulating or serpentine ring structure which is diametricallyexpansible. As illustrated in filter members 110, 120 and 130, apicalportions of each undulating or serpentine ring structure isinterconnected by an interconnecting member 114, 124, 134, respectively,either with an adjacent ring structure, as in filter member 110 or to adistal end 20 of the filter member itself. A longitudinally serpentinesection 132 in filter 32 may be provided in conjunction with theinterconnecting member 134, to afford greater expansive properties tothe hoop or circumferential member 137.

According to some embodiments particularly well-suited for placement byfemoral or other infrarenal approach, the filter member 16 ischaracterized by a generally conical filter member 16 having a greateropen surface area exposed to the flow of embolic material into thefilter at its proximal end, while the distal end has smaller opensurface area exposed to the flow of embolic material to capture theembolic material in the distal end of the filter member.

In other embodiments particularly well-suited for placement by a jugularor suprarenal approach, the filter member 16 is characterized by agenerally conical filter member 16 having a greater open surface areaexposed to the flow of embolic material into the filter at its distalend, which the proximal end of the filter member 16 has a smaller opensurface area exposed to the flow to capture smaller embolic material inthe distal end of the filter member 16.

Additionally, in all of the embodiments the filter member 16 isself-centering to provide proper apposition against the vascular wallsand centering within the lumen of a blood vessel. This maximizes theflow dynamics of the filter member 16 within the blood vessel forpurposes of capturing embolic material within the struts of the filterand centers the catheter body member 12 within the vascular lumen.

As noted above, the proximal 32 and distal 34 ports serve as means formeasuring flow rates or pressure differentials across the filter 16.This may be accomplished by including flow sensors and/or pressuretransducers 19 in operable association with each port 32, 34, with theassociated electrical connections to the flow sensors an/or pressuretransducers 19 passing through the respective lumens associated witheach port 32, 34 and terminating at the proximal end of the catheterbody 12. Where flow sensors 19 are employed, a single flow sensorassociated with either proximal port 32 or distal port 34 may besufficient to detect fluid flow rates at the position of the catheterbody 12. Alternatively, the flow sensors and/or pressure transducers 19may reside in communication with the lumens respectively associated witheach port 32, 34 at the proximal end of the catheter body 12, therebyeliminating the need for electrical connectors resident with theassociated lumens. Furthermore, wireless flow sensors and/or pressuretransducers may be provided in communication with each port 32, 34, andbe operably coupled to a power source and a transmitter to wirelesslytransmit telemetry data from the transducers to a wireless receiver incommunication with the transmitter, as is known in the art.

Alternatively, the proximal 32 and distal ports 34 may be used formonitoring or sensing other conditions in the body that are detectablein the blood. For example, analyte sensors may be introduced to eitherthe lumens communicating with the proximal 32 or distal ports 34 or tothe ports themselves to monitor and/or sense chemical or biochemicalconditions in the body. An example of this application is monitoring orsampling blood glucose levels for diabetes control. Further, theproximal 32 and distal ports 34 may be used for fluid infusion or forwithdrawal or evacuation of fluids or other material through thecatheter body 12. In this later instance, where the proximal port 32 ispositioned to underlay the filter member 16, thrombus collected in thefilter member 16 may capable of being lysed, either by thrombolysisthrough the infusion ports 36 or under the influence of thermal ormechanical lysis, such as by introducing a laser, ultrasound or othersystem capable of lysing thrombus, which may be introduced through thelumen communicating with the proximal port 32, or the distal port 32 orthe guidewire lumen 30, or introduced separately from the CVAF 10,positioned within the space bounded by the filter member 16, lysingthrombus collected in the filter member 16 and evacuating the lysedthrombus through the proximal port 32

It is known that flow velocity increases proximally within the venoussystem. For example a flow rate of 1 L/min is typical in one femoralvein, increases to 2 L/min in the inferior vena cava and increasinganother 0.7 to 1 L/min proximate the renal veins. Knowing the typicalflow rates coupled with a flow sensor 19 associated with the multi-lumencatheter body 12 may serve to supplement or replace the requirements forfluoroscopy or sonography in placement of the CVAF 10, 50.

Other sensors, such as, for example, chemosensors, color sensors,optical sensors, electrical sensors or biosensors, may be employed inlieu of or in addition to pressure transducer and/or a flow sensor 19 inorder to detect other changes or conditions within the patient'svasculature. For example, color sensors exist that sense color changesin thrombus, such color changes may be displayed and interpreted by themedical practitioner as an indication of thrombus staging. Analytesensors, such a as a glucose sensor or an oxygen saturation sensor mayalso be employed.

The filter member 16, or its alternative embodiments described above,may be fixed to the catheter body 12 or may be removably coupled to thecatheter body 12 for deployment as either a permanent filter or as atemporary and retrievable vena cava filter. Removable coupling of thefilter member to the catheter body 12 may be accomplished with a varietyof release and retrieval mechanisms operably associated the catheterbody 12 and proximate the diametric transition 15. Non-limiting examplesof such release and retrieval mechanisms include a wire release thatengages with a the proximal end 18 of the filter, a cooperating indexeddetent and projection interaction between the catheter body 12 and theproximal end 18 of the filter, such as a detent in the proximal end ofthe filter and a cooperating projection in the multi-lumen catheter thatis positionally indexed to the detent and releasable from the detent,or, alternatively, a helical slot or threads may be formed in theproximal end 18 of the filter and indexed and cooperating projection inthe multi-lumen catheter than permits engagement and disengagement withthe helical slot or threads.

As depicted in FIGS. 16A and 16B, which depict the undeployed state(FIG. 16A) and the deployed state (FIG. 16B) of the filter member 216,respectively, common to each of the embodiments of the present invention200 is an inner catheter 214 that carries the vena cava filter 216 at adistal end thereof. The inner catheter 214 is concentrically andreciprocally engaged within an outer sheath 222 such that relative axialmovement of the inner catheter 214 and the outer sheath 222 eitherexposes the vena cava filter 216 for deployment or captures the venacava filter 216 for retrieval. A first hub member 225 is coupled to aproximal end of the outer sheath 222 and a second hub member 227 iscoupled to a proximal end of the inner catheter 214. First hub member225 and second hub member 227 are engageable, such as by a threaded,bayonet, snap fit, friction fit or interference fit fitting, to securethe inner catheter 214 within the outer sheath 222 and restrict relativeaxial movement of the two elements after deployment of the vena cavafilter 216. A flush line 229 communicates with the first hub member 225and is in fluid communication with a luminal space within the outersheath 222. A plurality of fluid lines 231, 233, 235, 237 communicatewith the second hub member 227 and are each in fluid communication withone of the plural lumens within the inner catheter member 214, e.g.,lumens communicating with the proximal, distal or infusion ports (notshown). A distal tip 26 is provided at a distal end of the innercatheter.

In an alternative embodiment, as depicted in FIGS. 17A-D, the centralvenous access catheter 1600 comprises a multi-lumen catheter body 1602and an outer sheath 1622 concentrically disposed about the multi-lumencatheter body 1602. The multi-lumen catheter body 1602 has plurallongitudinally extending lumens that pass longitudinally through thecatheter body 1602 and are substantially parallel to each other withinthe catheter body 1602. Each of the plural lumens reside within a singlecatheter body. The plural lumens define a first lumen 1604 having afirst lumen profile. In the embodiment depicted in FIG. 17A, thetransverse cross-sectional shape of the multi-lumen catheter body 1602is circular and the transverse cross-sectional shape of the first lumenprofile is also generally circular. In this embodiment, the first lumen1604 is configured as a central guidewire lumen, permitting a guidewireto pass therethrough.

Also as depicted in the embodiment in FIG. 17A, the multi-lumen catheterbody 1602 further defines at least one second lumen 1606 having a secondlumen profile that is different than the first lumen profile. In thisembodiment, the second lumen profile is again generally circular and hasa diameter that is not equal to the diameter of the first lumen profile.In this embodiment, the diameter of the second lumen profile is lessthan the diameter of the first lumen profile. The second lumen 1606 isconfigured to permit fluid flow therethrough. As depicted in FIG. 17A,two or more second lumens 1606 may be provided in the multi-lumencatheter body 1602, with the second lumens 1606 being positionedlaterally adjacent and parallel each other within the multi-lumencatheter body 1602.

The multi-lumen catheter body 1602 embodiment depicted in FIG. 17Afurther comprises a third lumen 1608 that has a third lumen profile thatis different from at least one of the first lumen profile and the secondlumen profile. In this embodiment, the third lumen profile is differentfrom both the first lumen profile and the second lumen profile.Furthermore, the third lumen profile is generally circular. In thisembodiment, the third lumen profile has a diameter that is less than thediameters of both the first lumen profile and the second lumen profile.The third lumen 1608 is configured to permit either a reinforcing memberto be disposed therethrough or to permit fluid flow therethrough.

FIG. 17B depicts an embodiment of the central access vena cava filtercatheter 1600 similar in general configuration as that depicted in FIG.17A, except that the multi-lumen catheter body 1602 only has a firstlumen 1604 and a second lumen 1606 passing longitudinally therethrough.Again, the transverse cross-sectional shape of the multi-lumen catheterbody 1602 is generally circular, as is the transverse cross-sectionalshape of the lumen profiles of each of the first lumen 1604 and thesecond lumen 1604. Also, as with the embodiment depicted in FIG. 17A,the diameter of first lumen 1604 is different than the diameter of thesecond lumen 1606, in this case, as depicted, the diameter is smallerthan that of the second lumen 1606.

FIG. 17C depicts an alternative embodiment of the central access venacava filter catheter 166 in which the transverse cross-sectional shapeof the multi-lumen catheter body 1602 is non-circular, and has twogenerally planar and elongate side walls 1603 and 1605 and two generallycurved or radiused walls 1607 and 1609 that connect each of the elongateside walls 1603 and 1605 at both ends thereof. In this embodiment, theelongate side walls 1603 and 1605 are non-parallel to each other, suchthat the radius of curvature R1 of one radius wall 1609 is less than theradius of curvature R2 of the second radius wall 1607. Thisconfiguration permits the first lumen 1604 to have a larger diameterthan that of the second lumen 1606. It will be understood, however, bythose skilled in the art, that the elongate side walls 1603 and 1605 maybe configured to be parallel to each other and that the radius wallshaving the same radius of curvature such that R1 is equal to R2. In thislater case, the first lumen 1604 and the second lumen 1606 may stillhave different diameters or may be configured to have like diameters.

In the embodiment depicted in FIG. 17C, at least one and, preferablytwo, fourth lumens 1610 are provided that pass longitudinally throughthe multi-lumen catheter body 1602 and are parallel to each other and tothe first 1604 and second 1606 lumens. In this case, the two fourthlumens 1610 are disposed laterally separated from each other along aplane P1 that is generally intermediate the first 1604 and second 1606lumens and resides within the multi-lumen catheter body 1602 and notintersecting with either of the first 1604 or second 1606 lumens. Aswith the third lumen 1608 depicted in FIG. 17A, the fourth lumen 1610may be used to retain a reinforcing member therein.

Finally, as depicted in FIG. 17D, the transverse cross-sectional shapeof the multi-lumen catheter body 1602 is generally ovular. As with theembodiments in FIG. 17B and FIG. 17C, a first lumen 1604 and a secondlumen 1606 pass longitudinally through the multi-lumen catheter body andare parallel to each other. The transverse cross-sectional shapes of thefirst lumen 1604 and the second lumen 1606 are generally circular andmay have equal or unequal diameters. Like with the embodiment depictedin FIG. 17C, there is provided at least one and, preferably two, fourthlumens 1610 are provided that pass longitudinally through themulti-lumen catheter body 1602 and are parallel to each other and to thefirst 1604 and second 1606 lumens. In this case, the two fourth lumens1610 are disposed laterally separated from each other along a plane P1that is generally intermediate the first 1604 and second 1606 lumens andresides within the multi-lumen catheter body 1602 and not intersectingwith either of the first 1604 or second 1606 lumens. Again, as with thethird lumen 1608 depicted in FIG. 17A, the fourth lumen 1610 may be usedto retain a reinforcing member therein.

The third lumen 1608 or the fourth lumen 1610, depending upon theembodiment, is configured to permit a reinforcing member to be disposedtherethrough. The reinforcing member adds longitudinal strength to themulti-lumen catheter body member 1602 to add both column strength to aidin pushability of the multi-lumen catheter body member 1602 and to addelongation strength to the multi-lumen catheter body member to aid inresisting longitudinal stretching of the material of the multi-lumencatheter body during re-positioning or withdrawal from the patient.

The reinforcing member is preferably a wire that is either disposedwithin the third lumen 1608 or the fourth lumen 1610 or is co-extrudedwith the multi-lumen catheter body 1602. It is preferable that thereinforcing member be fabricated of a biocompatible material, such asstainless steel, shape memory alloy, superelastic materials or elasticmaterials, including, without limitation, titanium, vanadium, aluminum,nickel, tantalum, zirconium, chromium, silver, gold, silicon, magnesium,niobium, scandium, platinum, cobalt, palladicum, manganese, molybdenumand alloys thereof, such as zirconium-titanium-tantalum alloys,cobalt-chromium-molybdenum alloys, nickel-titanium alloys or the like.The reinforcing member may be have a surface profile such as threads,raised structures, grooves, detents, depressions, or the like, to aid insecuring the reinforcing member within the third lumen 1608 or thefourth lumen 1610.

While the multi-lumen catheter body 1602 is depicted in FIGS. 17A-17Dand 18A-18D, with the illustrated transverse cross-sectional shapes, itwill be understood that alternative transverse cross-sectional shapesare envisioned by the present invention, including, without limitation,polygonal shapes, elliptical shapes, or complex curvilinear shapes, suchas petals about a central axis or the like.

The central access venous catheter 1600 further comprises an outersheath 1622 disposed substantially concentrically about the outside ofthe multi-lumen catheter body 1602 thereby forming a fluid passageway1614. In the instant embodiment, due to the shape of the body profile,the fluid passageway 1614 may be annular as depicted in FIGS. 17A and17B or non-annular as depicted in FIGS. 17C and 17D. It will beunderstood that the fluid passageway 1614 has a large cross-sectionalsurface area and is well suited for infusing larger volumes of fluid tothe distal end of the central access venous catheter 1600 than thatpossible through any of the first, second, third or fourth lumens.

Finally, each if the first lumen 1604, the second lumen 1606, the thirdlumen 1608 and the fourth lumen 1610 extend to a distal aspect of themulti-lumen catheter body and open at a distal aspect of the multi-lumencatheter body. The first lumen 1604, when used as a guidewire lumen,will extend the entire longitudinal length of the inventive centralaccess vena cava filter catheter 1600 and open, in fluid flowcommunication, at substantially a very distal end of the catheter 1600.The second lumen 1606 may extend to a point generally proximal to theposition of the vena cava filter member 14 and be skived or otherwiseopen in fluid flow communication through a side wall of the multi-lumencatheter body member 1602 to permit fluid flow to exist a distal end ofthe second lumen 1606. When used for fluid flow, the third lumen 1608 orthe fourth lumen 1610 may terminate in a skive or be otherwise open influid flow communication through a side wall of the multi-lumen catheterbody member 1602 to permit fluid flow to exit the multi-lumen catheterbody 1602. When used to retain a reinforcing member, the third lumen1608 and the fourth lumen 1610 will preferably extend a substantialaspect of the multi-lumen catheter body member 1602 to afford maximalreinforcing capacity. Finally, the fluid passageway 1614 being definedbetween outer sheath 1622 and the multi-lumen catheter body 1602, willterminate and be open at a distal end of the outer sheath 1622, theposition of which relative to the multi-lumen catheter body 1602 isvariable.

Thus there has been described a central venous access filter inaccordance with the foregoing embodiments of the invention whichinclude, generally, a multi-lumen catheter body, a filter member and anintroducer sheath. The multi-lumen catheter body has a plurality ofports each of which are in fluid flow communication with at least onelumen in the multi-lumen catheter body. Lumens may include a centralguidewire lumen useful for tracking over a guidewire and/or largervolume infusion of bioactive agents, intravenous fluids, bloodtransfusions, or other fluids; infusion lumens in communication withinfusion ports positioned to direct fluids to the space bounded by thefilter member for introducing bioactive agents, including thrombolyticagents or flushing agents, including pressurized fluids for mechanicalthrombolysis directly to the capture site of the thrombus in the filtermember; and lumens communicating with proximal and distal ports whichmay also be used for fluid introduction and/or may house or communicatewith sensors, such as pressure transducers, flow sensors, analytesensors, color sensors, optical sensors or the like. The filter membermay be detachable from the multi-lumen catheter body to permit temporaryfilter placement and later retrieval by a detachment mechanism thatcooperates between the filter and the multi-lumen catheter body. Theseand other aspects of the present invention are provided by way ofnon-limiting examples, with the claims appended hereto serving to definethe scope of the subject matter regarded as the invention.

What is claimed is:
 1. A multi-lumen catheter comprising: a singlecatheter body member of a unitary material having a first lumen in thesingle catheter body member, the first lumen having a first transverselumen cross-section, a second lumen in the single catheter body member,the second lumen having a second transverse lumen cross-section that isdifferent from the first transverse lumen cross-section, and a thirdlumen in the single catheter body member, the third lumen having a thirdtransverse lumen cross-section that is different from the firsttransverse lumen cross-section and the second transverse lumencross-section; wherein each of the first lumen, the second lumen and thethird lumen reside within the single catheter body member, are laterallyadjacent and parallel to each other and each have a proximal opening anda distal opening; at least one elongate reinforcing member fixed withinthe unitary material of the single catheter body member or not in any ofthe first lumen, second lumen or third lumen; and a sheath disposedabout the body member, wherein the sheath forms a non-annular fluidpassageway around an outside surface of the body member.
 2. Themulti-lumen catheter of claim 1, wherein the reinforcing membercomprises a biocompatible wire member.
 3. The multi-lumen catheter ofclaim 2, wherein the reinforcing member is composed of a biocompatiblematerial selected from the group consisting of nickel, titanium,vanadium, aluminum, tantalum, zirconium, chromium, silver, gold,silicon, magnesium, niobium, scandium, platinum, cobalt, palladium,manganese, molybdenum and alloys thereof, including stainless steel,nitinol, cobalt-chromium-molybdenum alloys, andzirconium-titanium-tantalum alloys.
 4. The multi-lumen catheter of claim1, wherein the body member further comprises a fourth lumen having afourth transverse lumen profile.
 5. The multi-lumen catheter of claim 4,wherein the fourth transverse lumen profile is similar to the thirdtransverse lumen profile.
 6. The multi-lumen catheter of claim 1,wherein the body member has a generally oval transverse cross-sectionalprofile.
 7. The multi-lumen catheter of claim 6, wherein the first andsecond lumens are generally circular in transverse cross-sectional shapeand the first lumen has a diameter less than a diameter of the secondlumen.
 8. The multi-lumen catheter of claim 7, wherein the third lumenand a fourth lumen pass through the body member at a plane that residesgenerally intermediate the first lumen and the second lumen.
 9. Themulti-lumen catheter of claim 1, wherein the body member has a generallycircular transverse cross-sectional profile.
 10. The multi-lumencatheter of claim 9, wherein the first and second lumens are generallycircular in transverse cross-sectional shape and the first lumen has adiameter less than a diameter of the second lumen.
 11. The multi-lumencatheter of claim 10, wherein the third lumen and a fourth lumen passthrough the body member at a plane that resides generally intermediatethe first lumen and the second lumen.
 12. The multi-lumen catheter ofclaim 9, further comprising a fourth lumen and a fifth lumen passingthrough the body member and parallel to the first lumen, the secondlumen and the third lumen and each other; the fourth lumen having asubstantially identical transverse lumen profile as the second lumen andthe fifth lumen have a substantially identical transverse lumen profileas the third lumen.
 13. The multi-lumen catheter of claim 12, whereinthe second lumen and the third lumen each have a generally circulartransverse lumen profile.
 14. The multi-lumen catheter of claim 13,wherein the first lumen has a generally circular transverse lumenprofile and a diameter that is greater than the diameter of the secondlumen profile and the third lumen profile.
 15. The multi-lumen catheterof claim 1, further comprising a vena cava filter member disposedconcentrically about a distal end of the body member.
 16. Themulti-lumen catheter of claim 15, further comprising an outer sheathconcentrically disposed about the body member and the vena cava filtermember and reciprocally moveable relative thereto.
 17. A multi-lumencatheter comprising: a single catheter body member of a unitary materialhaving a first lumen in the single catheter body member, the first lumenhaving a first transverse lumen cross-section, a second lumen in thesingle catheter body member, the second lumen having a second transverselumen cross-section that is different from the first transverse lumencross-section, and a third lumen in the single catheter body member, thethird lumen having a third transverse lumen cross-section that isdifferent from the first transverse lumen cross-section and the secondtransverse lumen cross-section; wherein each of the first lumen, thesecond lumen and the third lumen reside within the single catheter bodymember, are laterally adjacent and parallel to each other and each havea proximal opening and a distal opening; at least one elongatereinforcing member fixed within the unitary material of the singlecatheter body member or not in any of the first lumen, second lumen orthird lumen; and wherein the body member has a generally transversecross-sectional shape having two generally planar lateral side walls, afirst curvilinear surface connecting one end of the two generally planarlateral side walls and a second curvilinear surface connecting a secondend of the two generally planar lateral side walls.
 18. The multi-lumencatheter of claim 17, wherein the first curvilinear surface has a radiusless than the second curvilinear surface.
 19. The multi-lumen catheterof claim 17, wherein first lumen and the second lumen are generallycircular in transverse cross-sectional shape and the first lumen has adiameter less than a diameter of the second lumen.
 20. The multi-lumencatheter of claim 19, wherein the third lumen and a fourth lumen passthrough the body member at a plane that resides generally intermediatethe first lumen and the second lumen.
 21. The multi-lumen catheter ofclaim 17, wherein the reinforcing member comprises a biocompatible wiremember.
 22. The multi-lumen catheter of claim 21, wherein thereinforcing member is composed of a biocompatible material selected fromthe group consisting of nickel, titanium, vanadium, aluminum, tantalum,zirconium, chromium, silver, gold, silicon, magnesium, niobium,scandium, platinum, cobalt, palladium, manganese, molybdenum and alloysthereof, including stainless steel, nitinol, cobalt-chromium-molybdenumalloys, and zirconium-titanium-tantalum alloys.
 23. The multi-lumencatheter of claim 17, further comprising a vena cava filter memberdisposed concentrically about a distal end of the body member.
 24. Themulti-lumen catheter of claim 23, further comprising an outer sheathconcentrically disposed about the body member and the vena cava filtermember and reciprocally moveable relative thereto.